BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM

    MDR report key: 2437737 · Received January 23, 2012

    Report

    Report Number
    2437737
    Event Type
    Malfunction
    Date Received
    January 23, 2012
    Date of Event
    January 10, 2012
    Report Date
    January 23, 2012
    Manufacturer
    SIGMA
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    SYSTEM FAILED. PROVIDED THE FOLLOWING MESSAGE: SYSTEM ERROR 322 LINK SWITCH ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPECTRUM INFUSION PUMP FRN SIGMA * *

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR